A Study to Assess the Efficacy and Safety of Alefacept in Kidney Transplant Recipients

Astellas

Status and phase: Completed; Phase 2

Conditions: De Novo Kidney Transplantation

Treatments: Drug: Alefacept; Drug: Tacrolimus; Drug: Steroids; Drug: placebo; Drug: Mycophenolate Mofetil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00617604

2007-002092-14 (EudraCT Number)

0485-CL-E201

Details and patient eligibility

About

The purpose of this study is to determine whether alefacept is effective and well tolerated when used with a combination of tacrolimus, mycophenolate mofetil and steroids versus a combination therapy of placebo, tacrolimus and steroids in the prevention of kidney transplant rejection.

Enrollment: 218 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject with end stage kidney disease who is a suitable candidate for primary kidney transplantation or retransplantation
• Male or female subject at least 18 years of age and younger than 65 years
• Subject receiving a kidney transplant from a non-human leucocyte antigen (HLA) identical living donor or deceased HLA identical/non-HLA identical donor between 5 and 59 years of age with compatible ABO blood type (Blood group system A, B, AB and 0)

Exclusion criteria

• Subject has a panel reactivity antibody grade > 20% in the previous 6 months and/or had had a previous graft survival shorter than 1 year due to immunological reasons
• Subject received a kidney transplant from a non-heart beating donor
• Subject has received a kidney transplant from a 50 - 59 year old donor with two of the following three factors: history of hypertension, cerebrovascular accident as cause of death, final pre-procurement serum creatinine > 1.5 mg/dL (united network for organ sharing [UNOS] expanded criteria donor)
• Cold ischemia time of the donor kidney is ≥ 30 hours

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

218 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.

Treatment:

Drug: Mycophenolate Mofetil

Drug: Steroids

Drug: Tacrolimus

Drug: placebo

Alefacept

Experimental group

Description:

Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.

Treatment:

Drug: Mycophenolate Mofetil

Drug: Steroids

Drug: Tacrolimus

Drug: Alefacept